Abstract Background In patients with acute heart failure (AHF), dyspnea relief is the most immediate goal. Renal dysfunction, diuretic resistance, and hyponatremia represent treatment impediments. ...Objectives It was hypothesized that the addition of tolvaptan to a background diuretic improved dyspnea early in patients selected for an enhanced vasopressin antagonism response. Methods In a double-blind trial, patients were randomized to tolvaptan 30 mg/day or placebo. Study entry required hospitalization within the previous 36 h, active dyspnea, and any of the following: 1) estimated glomerular filtration rate <60 ml/min/1.73 m2 ; 2) hyponatremia; or 3) diuretic resistance (urine output ≤125 ml/h following intravenous furosemide ≥40 mg). The primary endpoint was a 7-point change in self-assessed dyspnea at 8 and 16 h, using a novel standardized approach. Results We randomized 250 patients. There was no difference in the primary endpoint of day 1 dyspnea reduction, despite significantly greater weight reduction with tolvaptan (−2.4 ± 2.1 kg vs. −0.9 ± 1.8 kg; p < 0.001). At day 3, dyspnea reduction was greater with tolvaptan (p = 0.01). There were 2 significant treatment-by-subgroup interactions: patients without elevated jugular venous pressure and those without ascites showed directional favorability of tolvaptan over placebo for the primary endpoint compared with patients with these findings. Conclusions Despite rapid and persistent weight loss with tolvaptan compared with placebo, in patients with AHF who were selected for greater potential benefit from vasopressin receptor inhibition, tolvaptan was not associated with greater early improvement in dyspnea. Apparent subsequent differences in dyspnea warrant further exploration of the temporal relationship between diuresis and dyspnea relief and a possible clinical role for tolvaptan. (Randomized, Double-Blind, Placebo Controlled Study of the Short Term Clinical Effects of Tolvaptan in Patients Hospitalized for Worsening Heart Failure With Challenging Volume Management SECRET of CHF; NCT01584557 )
Summary Background Malaria is endemic in 13 of 64 districts in Bangladesh. About 14 million people are at risk. Some evidence suggests that the prevalence of malaria in Bangladesh has decreased since ...the the Global Fund to Fight AIDS, Tuberculosis and Malaria started to support the National Malaria Control Program (NMCP) in 2007. We did an epidemiological and economic assessment of malaria control in Bangladesh. Methods We obtained annually reported, district-level aggregated malaria case data and information about disbursed funds from the NMCP. We used a Poisson regression model to examine the associations between total malaria, severe malaria, malaria-attributable mortality, and insecticide-treated net coverage. We identified and mapped malaria hotspots using the Getis-Ord Gi* statistic. We estimated the cost-effectiveness of the NMCP by estimating the cost per confirmed case, cost per treated case, and cost per person of insecticide-treated net coverage. Findings During the study period (from Jan 1, 2008, to Dec 31, 2012) there were 285 731 confirmed malaria cases. Malaria decreased from 6·2 cases per 1000 population in 2008, to 2·1 cases per 1000 population in 2012. Prevalence of all malaria decreased by 65% (95% CI 65–66), severe malaria decreased by 79% (78–80), and malaria-associated mortality decreased by 91% (83–95). By 2012, there was one insecticide-treated net for every 2·6 individuals (SD 0·20). Districts with more than 0·5 insecticide-treated nets per person had a decrease in prevalence of 21% (95% CI 19–23) for all malaria, 25% (17–32) for severe malaria, and 76% (35–91) for malaria-associated mortality among all age groups. Malaria hotspots remained in the highly endemic districts in the Chittagong Hill Tracts. The cost per diagnosed case was US$0·39 (SD 0·02) and per treated case was $0·51 (0·27); $0·05 (0·04) was invested per person per year for health education and $0·68 (0·30) was spent per person per year for insecticide-treated net coverage. Interpretation Malaria elimination is an achievable prospect in Bangladesh and failure to push for elimination nearly ensures a resurgence of disease. Consistent financing is needed to avoid resurgence and maintain elimination goals. Funding None.
Background The objective of the study was to determine whether the effects of infarct-related artery (IRA) infusion of autologous bone marrow–derived CD34+ cells after ST elevation myocardial ...infarction (STEMI) are dependent on the dose (quantity and mobility) of the cells infused. Beneficial effects of IRA infusion of mononuclear cells after STEMI have been inconsistent, possibly because of differences in timing, cell type, quantity, and mobility of infused cells. Methods Patients were randomized to bone marrow harvest (n = 16) or control (n = 15). At a median of 8.3 days after coronary stenting for STEMI, CD34+ cells were infused via the IRA at 3 dose levels (5, 10, and 15 × 106 ) in cohorts of 5 patients each. Baseline and follow-up imaging and ex vivo CD34+ cell mobility were performed. Results Cell harvest and infusion were safe. Quantitative rest hypoperfusion score measured by single-photon emission computed tomography improved at 6 months in the ≥10 million cohorts compared with controls (−256 vs +14, P = .02). There was a trend toward improved ejection fraction at 6 months (+4.5%) in the ≥10 million cohorts compared with no change in the controls and 5 million cohort (+0.7%). Improved perfusion and infarct size reduction correlated with the quantity and mobility of the infused CD34+ cells. Conclusions The effects of CD34+ cell IRA infusion during the repair phase after STEMI are dose dependent and, at a threshold dose of 10 million CD34+ cells, associated with a significant improvement in perfusion that may limit deterioration in cardiac function (IRA infusion of CD34+ cells in patients with acute myocardial infarction AMR-01 NCT00313339).
Background Developing patient-centered approaches to health care requires increased engagement of patients in their own care, including treatment decisions. Current levels of patient involvement in ...treatment choices have not been quantified, however, and whether patients desire greater decision-making responsibility is unknown. We conducted a prospective study to explore patients' desired vs experienced roles in treatment decisions, characterize perceptions of treatment outcomes, and identify important sources of information. Methods Patients undergoing elective vascular procedures completed a survey consisting of multiple choice, Likert scale, and open-ended questions. Statistics are displayed as mean ± standard deviation or count (%). Differences among procedure categories were evaluated using χ2 or the Fisher exact test at P < .05 based on responses scored 1 to 2, indicating importance, agreement, or satisfaction based on a 1 to 5 Likert scale where 1 = “very important,” “strongly agree” or “very satisfied”. Results Of 101 patients who were contacted, 81 participated. Procedure categories included abdominal aortic aneurysm (AAA) repair in 20, arteriovenous (AV) hemodialysis access in 21, carotid endarterectomy (CEA) in 20, and intervention for lower extremity peripheral arterial disease (PAD) in 20. Participants preferred discussion of all treatments being considered vs only the provider's recommended treatment (90% vs 56%) and choosing together with the provider vs having the provider choose for them (93% vs 62%). Although participants indicated adequate information to ask questions without feeling overwhelmed, only 77% agreed that they had the opportunity to ask questions and only 54% indicated that they were offered a choice. Thirty-seven participants (46%) considered their first treatment was successful, 38% considered a subsequent treatment was successful, and 16% considered none of their treatments were successful. Participants undergoing PAD and AV access procedures most often felt confused or overwhelmed (25% and 24%, respectively, vs 0% for AAA and CEA; P < .01). Patients with PAD had adequate information least often (70% vs 85% for AAA, 100% for AV access, and 95% for CEA; P = .01), had the lowest satisfaction with understanding of their diagnosis (65% vs 95% for AAA, 100% for AV access, and 95% for CEA; P < .01), and most often considered none of their treatments successful (35% vs 0% for AAA, 15% for AV access, and 15% for CEA; P = .02). Providers were identified as the most important information source. Conclusions Patients have variable levels of participation in decision making related to vascular procedures and often consider their treatments unsuccessful. Although providers are important sources of information, patients still prefer to discuss all options being considered and contribute to shared decision making.
Objectives The aim of this study was to determine the effect of stress cardiac magnetic resonance (CMR) imaging in an observation unit (OU) on revascularization, hospital readmission, and recurrent ...cardiac testing in intermediate-risk patients with possible acute coronary syndromes (ACS). Background Intermediate-risk patients commonly undergo hospital admission with high rates of coronary revascularization. It is unknown whether OU-based care with CMR is a more efficient alternative. Methods A total of 105 intermediate-risk participants with symptoms of ACS but without definite ACS on the basis of the first electrocardiogram and troponin were randomized to usual care provided by cardiologists and internists (n = 53) or to OU care with stress CMR (n = 52). The primary composite endpoint of coronary artery revascularization, hospital readmission, and recurrent cardiac testing at 90 days was determined. The secondary endpoint was length of stay from randomization to index visit discharge; safety was measured as ACS after discharge. Results The median age of participants was 56 years (range 35 to 91 years), 54% were men, and 20% had pre-existing coronary disease. Index hospital admission was avoided in 85% of the OU CMR participants. The primary outcome occurred in 20 usual care participants (38%) versus 7 OU CMR participants (13%) (hazard ratio: 3.4; 95% confidence interval: 1.4 to 8.0, p = 0.006). The OU CMR group experienced significant reductions in all components: revascularizations (15% vs. 2%, p = 0.03), hospital readmissions (23% vs. 8%, p = 0.03), and recurrent cardiac testing (17% vs. 4%, p = 0.03). Median length of stay was 26 h (interquartile range: 23 to 45 h) in the usual care group and 21 h (interquartile range: 15 to 25 h) in the OU CMR group (p < 0.001). ACS after discharge occurred in 3 usual care participants (6%) and no OU CMR participants. Conclusions In this single-center trial, management of intermediate-risk patients with possible ACS in an OU with stress CMR reduced coronary artery revascularization, hospital readmissions, and recurrent cardiac testing, without an increase in post-discharge ACS at 90 days. (Randomized Investigation of Chest Pain Diagnostic Strategies; NCT01035047 )
Abstract Background We performed a prospective, randomized investigation assessing the incremental effect of automated health monitoring (AHM) technology over and above that of a previously described ...nurse directed heart failure (HF) disease management program. The AHM system measured and transmitted body weight, blood pressure, and heart rate data as well as subjective patient self-assessments via a standard telephone line to a central server. Methods and Results A total of 188 consented and eligible patients were randomized between intervention and control groups in 1:1 ratio. Subjects randomized to the control arm received the Specialized Primary and Networked Care in Heart Failure (SPAN-CHF) heart failure disease management program. Subjects randomized to the intervention arm received the SPAN-CHF disease management program in conjunction with the AHM system. The primary end point was prespecified as the relative event rate of HF hospitalization between intervention and control groups at 90 days. The relative event rate of HF hospitalization for the intervention group compared with controls was 0.50 (95%CI 0.25–0.99, P = .05). Conclusions Short-term reductions in the heart failure hospitalization rate were associated with the use of automated home monitoring equipment. Long-term benefits in this model remain to be studied.
Objectives To examine the combined influence of physical activity and screen time (television and video games) on the odds of being overweight and to evaluate the utility of current public policy ...recommendations. Study design Physical activity was assessed by a pedometer and screen time was assessed by survey in a sample of 709 children age 7 to 12 years. The percentage of subjects meeting current physical activity and screen time recommendations was calculated. Cross-tabulated physical activity–screen time groups were formed depending on whether or not the children were meeting current recommendations. Logistic regression was used to examine the influence of physical activity and screen time on the odds of being overweight. Results Children meeting physical activity and screen time recommendations were the least likely to be overweight. Approximately 10% of the boys and 20% of the girls meeting both recommendations were overweight, compared with 35% to 40% of those who did not meet either recommendation. Screen time and physical activity appeared to be equivalent risk factors for boys, even though physical activity in girls was more strongly associated with body mass index. Conclusions Children not meeting the physical activity or screen time recommendations were 3 to 4 times more likely to be overweight than those complying with both recommendations.
Abstract Background Outpatient care accounts for a significant proportion of total heart failure (HF) expenditures. This observation, plus an expanding list of treatment options, has led to the ...development of the disease-specific HF clinic. Methods and Results The goals of the HF clinic are to reduce mortality and rehospitalization rates and improve quality of life for patients with HF through individualized patient care. A variety of staffing configurations can serve to meet these goals. Successful HF clinics require an ongoing commitment of resources, the application of established clinical practice guidelines, an appropriate infrastructure, and a culture of quality assessment. Conclusions This consensus statement will identify the components of HF clinics, focusing on systems and procedures most likely to contribute to the consistent application of guidelines and, consequently, optimal patient care. The domains addressed are: disease management, functional assessment, quality of life assessment, medical therapy and drug evaluation, device evaluation, nutritional assessment, follow-up, advance planning, communication, provider education, and quality assessment.
Background Lymphangiogenesis responds to tissue injury as a key component of normal wound healing. The development of fibrosis in the idiopathic interstitial pneumonias may result from abnormal wound ...healing in response to injury. We hypothesize that increased lymphatic vessel (LV) length, a marker of lymphangiogenesis, is associated with parenchymal components of the fibroblast reticulum (organizing collagen, fibrotic collagen, and fibroblast foci), and its extent correlates with disease severity. Methods We assessed stereologically the parenchymal structure of fibrotic lungs and its associated lymphatic network, which was highlighted immunohistochemically in age-matched samples of usual interstitial pneumonia (UIP), nonspecific interstitial pneumonia (NSIP) with FVC < 80%, COPD with a Global Initiative for Obstructive Lung Disease stage 0, and normal control lungs. Results LV length density, as opposed to vessel volume density, was found to be associated with organizing and fibrotic collagen density ( P < .0001). Length density of LVs and the volume density of organizing and fibrotic collagen were significantly associated with severity of both % FVC ( P < .001) and diffusing capacity of the lung for carbon monoxide ( P < .001). Conclusions Severity of disease in UIP and NSIP is associated with increased LV length and is strongly associated with components of the fibroblast reticulum, namely organizing and fibrotic collagen, which supports a pathogenic role of LVs in these two diseases. Furthermore, the absence of definable differences between UIP and NSIP suggests that LVs are a unifying mechanism for the development of fibrosis in these fibrotic lung diseases.
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